Cullinan Oncology to Present New Preclinical Data for CLN-619 and CLN-617 at the 2023 American Association for Cancer Research Annual Meeting

CLN-619 is a MICA/B directed humanized IgG1 antibody being studied in a global Phase 1 clinical trial in patients with advanced solid tumors. Initial clinical data from the ongoing trial is on-track to be released mid-2023.

CLN-617 is a cytokine therapy combining IL-2 and IL-12 in a single molecule. An Investigational New Drug Application was recently submitted to the FDA for CLN-617.

CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc., (Nasdaq: CGEM) (“Cullinan Oncology”) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced that posters of preclinical data highlighting the therapeutic potential of two assets, CLN-619 and CLN-617, will be presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting taking place in Orlando, Florida, April 14-17, 2023.

Details of the Cullinan Oncology posters at AACR are as follows:

Poster Title: The Structural Basis for Inhibition of MICA Shedding and Anti-Tumor Activity of the Monoclonal Anti-MICA/B Antibody, CLN-619
Session: Therapeutic Antibodies 2
Session Date/Time: Monday, April 17, 2023, 1:30 pm – 5 pm ET
Location: Poster Section 23
Abstract Number: 2943
Poster Board Number: 21
Authors: Kerry A. Whalen, Naveen K. Mehta, Kristan Meetze, Jennifer S. Michaelson, Patrick A. Baeuerle

Poster Title: CLN-617 is a First-in-Class Fusion Protein That Retains IL-2 and IL-12 in the Injected Tumor and Potently Triggers Systemic Anti-Tumor Immunity
Session: Immunomodulatory Agents and Interventions 2
Session Date/Time: Monday, April 17, 2023, 9 am – 12:30 pm ET
Location: Poster Section 24
Abstract Number: 1839
Poster Board Number: 11
Authors: Naveen K. Mehta, Kavya Rakhra, Kristan Meetze, K. Dane Wittrup, Jennifer S. Michaelson, Patrick A. Baeuerle

“We are proud to present data at this year’s AACR conference for two programs in our diverse and robust pipeline, CLN-619 which is a MICA/B directed IgG1 antibody and CLN-617, an IL-2 and IL-12 cytokine therapy,” said Dr. Patrick Baeuerle, Chief Scientific Officer, Cullinan Oncology. “While distinct programs, each has the potential to be a first- and/or best-in-class therapy across a broad range of solid tumor types. We are excited to present more data on these two programs in poster presentations at AACR 2023 and highlight the strides we are making toward creating new standards of care for patients with cancer.”

The posters will expand on preclinical research that has been conducted for both molecules.

About CLN-619
CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that binds to the stress induced ligands, MICA and MICB, which are expressed on a wide variety of hematological and solid tumors. Engagement of MICA/B by the activating receptor NKG2D, present on both cytotoxic innate and adaptive immune cells, results in target cell lysis. However, tumor cells can shed MICA/B via proteases they release into the tumor microenvironment, resulting in evasion of immune-mediated destruction. CLN-619 functions by restoring MICA/B expression on the surface of tumor cells, enhancing the interaction between MICA and NKG2D, and inducing antibody-dependent cellular toxicity (ADCC), together promoting anti-tumor activity via NKG2D-expressing NK and T cells. CLN-619 is being studied in an ongoing Phase 1 clinical trial both as a monotherapy and in combination with pembrolizumab. The study design allows dose level extensions as well as expansion in tumor-specific cohorts. The trial was initiated in December 2021, and initial clinical data is anticipated in mid-2023.

About CLN-617
CLN-617 is a potential first-in-class cytokine therapy uniquely combining two potent and synergistic antitumor cytokines, IL-2 and IL-12, in a single molecule. The molecule is intended for intratumoral injection and employs collagen-binding and size-enhancing domains designed to retain the CLN-617 molecule inside the tumor and thereby enhance efficacy and reduce toxicity. While CLN-617 is injected and retained locally in the tumor, it directs a broad immune response that may help eradicate not only the injected tumor, but also attack distant tumor sites, as observed in preclinical studies. Pre-clinical studies have also demonstrated the potential for enhanced efficacy when CLN-617 is combined with checkpoint inhibitor therapy. Cullinan plans to evaluate CLN-617 in a phase 1 clinical trial in patients with advanced solid tumors.

About Cullinan Oncology        
Cullinan Oncology, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications. Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization. As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.

Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer. Learn more about our Company at www.cullinanoncology.com, and follow us on LinkedIn and Twitter.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan’s beliefs and expectations regarding the potential benefits and therapeutic potential of CLN-619 and CLN-617; our clinical development plans and timelines; our plans regarding future data presentations and other statements that are not historical facts. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts:

Investors
Cullinan Oncology:
Chad Messer
+1 203.464.8900
cmesser@cullinanoncology.com

Media 
Cullinan Oncology:
Rose Weldon
+1 215.801.7644
rweldon@cullinanoncology.com